Patient Claims Medtronic Infuse, Stryker OP-1 Putty were Used Off-Label without Her Consent

A California hospital is facing scrutiny over the way patients at the facility were treated with two controversial bone growth products, Stryker’s OP-1 Putty and Medtronic Inc.’s Infuse Bone Graft. According to a report from Mass Device.com, the California Department of Public Health launched an investigation of Pomona Valley Hospital after a patient filed suit alleging she suffered serious injuries after receiving Stryker OP-1 Putty and Medtronic Infuse in off-label procedures without her consent.

As we’ve reported previously, Stryker’s OP-1 Putty is a bone cement used to stimulate bone growth in long bones and the spine that was approved by the Food & Drug Administration (FDA) under a highly restrictive Humanitarian Device Exemption. In April, a former patient of Pomona Valley filed suit alleging she received Stryker’s OP-1 Putty in combination with a Calstrux bone-filler during surgery to relieve her back pain, a combination which has never been reviewed by the FDA. The plaintiff claims that the combination of OP-1 Putty and Calstrux bone filler caused excessive bone growth in her lower back, resulting in nerve compression and debilitating pain that required additional surgery.

According to the lawsuit, the plaintiff then received Medtronic’s Infuse Bone Graft product during a second procedure to repair the damage caused by her first surgery. Infuse, also known as recombinant human bone morphogenetic protein-2, or BMP-2, was approved for use in single-level anterior lumbar fusion. However, the Plaintiff alleges she received Infuse in an off-label posterior procedure.

According to the complaint, the off-label use of the OP-1 Putty and Infuse resulted in “agonizing pain” and forced the plaintiff into permanent disability. The lawsuit alleges that the makers of the two products illegally promoted their use in off-label procedures. The complaint further charges that internal hospital memos suggest that at least 16 other patients were involved in a secret research project to test the Stryker OP-1 Putty.

This isn’t the first time Stryker and Medtronic have been accused of illegally promoting their bone growth products. According to Mass Device, Stryker pled guilty to a misdemeanor earlier this year and agreed to pay $15 million to settle federal charges that it illegally promoted off-label use of the OP-1 Putty. The U.S. Justice Department recently closed a similar investigation of Medtronic Infuse without bringing any charges.

Last year, the Spine Journal raised serious questions about the validity of research used to gain FDA approval of Infuse. According to a critical analysis of 13 Medtronic-sponsored clinical trials for Infuse published by the Journal, the studies failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution, and worsened back and leg pain, in patients treated with Infuse.